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An Open-label, Randomised Multicenter Phase 3b Study to Determine the Confirmed Rate of Molecular Response ≥ 4 Log (MR4) at Two Years

NCT02174445 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-12-02

No results posted yet for this study

Summary

This is an open-label, multicenter, randomised phase 3b clinical trial of Imatinib 400 to 800 mg daily versus Nilotinib 300 mg two times daily in chronic phase CML patients with confirmed MMR without MR4.5

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

Imatinib

Imatinib, 400 to 800 mg p.o., daily

DRUG

Nilotinib

300mg p.o., twice-daily

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Prof. Dr. Nikolas von Bubnoff

    lead OTHER

Principal Investigators

  • Nikolas von Bubnoff, Professor · University Hospital Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2018-12-31
Completion
2019-10-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02174445 on ClinicalTrials.gov